NCT00768521

A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

Completed Phase 1 Results posted Last updated 22 February 2018

What this trial tests

Phase 1 trial testing tolterodine tartrate in Overactive Bladder in 20 participants. Completed in 19 January 2009.

Timeline

3 September 2008

Primary endpoint
19 January 2009

19 January 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	3 September 2008
Primary completion	19 January 2009
Estimated completion	19 January 2009

Drugs / interventions tested

• tolterodine tartrate — full drug profile →
• Comparator: Placebo to tolterodine tartrate — full drug profile →

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 40 to 75, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo Primary · 4 hours post dose 7

Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)

Group	Value	95% CI
Tolterodine	1.15	1.04 – 1.28
Placebo	0.94	0.84 – 1.04

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo Secondary · 4 hours post dose 1

Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)

Group	Value	95% CI
Tolterodine	0.92	0.83 – 1.02
Placebo	0.91	0.82 – 1.00

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse experiences reporting are from the randomization visit to follow-up phone call.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tolterodine

Serious: 0/20 (0%)

Deaths: —

Placebo

Serious: 0/20 (0%)

Deaths: —

Other adverse events (4 terms — click to expand)

Reaction	System	Tolterodine	Placebo
Diarrhoea	Gastrointestinal disorders	—	—
Dry Mouth	Gastrointestinal disorders	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Dysuria	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT00768521 adverse events section.

Sponsor's own description

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.